38th Annual
J.P. Morgan
Healthcare
Conference
Chirag Patel
Co-CEO and
President
January 15, 2020
Safe Harbor Statement
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward looking statements include statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as "may," "will," "could," "expect," "plan," "anticipate," "intend," "believe," "estimate," "assume," "continue," and similar words are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward- looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal Pharmaceuticals, Inc. (the "Company"). Such risks and uncertainties include, but are not limited to: our ability to successfully develop and commercialize new products; our ability to obtain exclusive marketing rights for our products and to introduce products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including United States federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; our reliance on certain licenses to proprietary technologies from time to time; our dependence on third party suppliers and distributors for raw materials for our products and certain finished goods; and our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future. A further list and descriptions of these risks, uncertainties and other factors can be found in the Company's most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 2018, as supplemented by any subsequently filed Quarterly Reports on Form 10-Q. Copies of these filings are available online at www.sec.gov, www.amneal.comor on request from the Company.
Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
2
Reinvigorating Amneal: Momentum Entering 2020
IMPLEMENTED
NECESSARY
BUSINESS
EVOLUTION
Strengthened new product launch
strategy & execution
Enhanced plant utilization & product revenue optimization
Strengthened forecast accuracies
Refocused Generics & Specialty
R&D
Heightened focus on IPX203 momentum & began to identify potential Specialty pipeline opportunities
DELIVERED
2019
OPERATIONAL
EXECUTION
A leader in U.S. generics approvals & launches
32 ANDAs approved +
7 tentative approvals
38 products launched, including Gx
Carafate® & first-to-market Gx
NuvaRing® in 4Q19
14 ANDAs submitted
Growth from Specialty products
Rytary® & Unithroid®
POSTIONED
AMNEAL FOR
FUTURE
GROWTH
Signed agreement to acquire majority interest in AvKARE, enhancing access to growing federal healthcare market
Established partnership with Kashiv Biosciences to expand CNS- focused Specialty pipeline with K127 Orphan Drug
Boosted strategic expertise with appointment of Jeff George, John Kiely & Shlomo Yanai to Board of Directors
3
Aggressively Positioning Amneal for Growth: 2020 Strategic Priorities
Grow Fundamentally Strong Generics Business
Grow Specialty Franchise | ||
Deliver value & volume growth | Complete AvKARE | |
for 2020 across various dosage | ||
forms, including injectables | Transaction (Feb. 2020) | |
Focus on growing topline, | ||
capturing pipeline opportunities | ||
& inorganic growth | Grow the Federal Healthcare | |
business through expansion of | ||
vendors & product offerings as | ||
well as unit dose product | ||
portfolio | ||
4
Grow Fundamentally Strong Generics Business
Deliver value & volume growth for 2020 across various dosage forms
- Improve Generics segment gross margins
- Address competitive market challenges to sustain portfolio of 225+ marketed products
- Extract additional value from base business
- Won new awards for 20 base business products (late 2019) that will be incremental in 2020
- 30+ other product opportunities identified
- Execute organic and inorganic opportunities to expand the business
- Strengthen government/unit dose business through AvKARE acquisition
- Evaluate geographic expansion opportunities
- Focus M&A on institutional markets and niche, difficult-to-manufacture products o Strengthen commitment to pipeline and product launch execution
- Enhance focus on complex/differentiated products (ophthalmics, inhalation, injectables)
- Leverage product launch capabilities to achieve first-to-market, CGT and other value-generating launches
5
Pipeline Focused on Complex & Differentiated Dosage
ANDAs Submitted (Pending + TA):
97 Projects
SoftGel 1%
Nasal Spray | 2% |
Transdermal 4%
Ophthalmic | 5% | ||||||||
Oral Liquid | 7% | ||||||||
Topical | 8% | ||||||||
Injection | 14% | ||||||||
ER | 15% | ||||||||
Tabs/Caps | |||||||||
IR Tabs/Caps | 42% | ||||||||
0% | 5% | 10% | 15% | 20% | 25% | 30% | 35% | 40% | 45% |
58% Solid dose
42% other dosage forms
Development Pipeline: | |||||||
73 projects | |||||||
Transdermal | 1% | ||||||
Soft Gel | 3% | ||||||
Nasal Spray | 4% | ||||||
Inhalation | 5% | ||||||
Oral Liquid | 7% | ||||||
ER Tabs/Caps | 10% | ||||||
Topical | 11% | ||||||
IR Tabs/Caps | 15% | ||||||
Ophthalmic/Otic | 16% | ||||||
Injection | 27% | ||||||
0% | 5% | 10% | 15% | 20% | 25% | 30% |
28% Solid dose
72% other dosage forms
6
Ensure Continued Generic Pipeline Execution
What We've Done: | What's Next: | |
1 | Notable Complex Generic Launches | Continued Pipeline Execution |
Generics |
Injectables
Transdermal
Topical/Ring
Oral Solids
Liquid/Nasal
Ophthalmic
7
(1) Generic versions of innovator products.
Continue to Build Specialty Franchise
Focus on Growing Specialty Topline
- Strengthen operational execution of well-established infrastructure and footprint in Neurology and Endocrinology/Primary Care
- IPX203 development program
- Licensing agreement (announced Nov. 2019) with Kashiv BioSciences for Exclusive U.S. rights for development & commercialization of K127 (pyridostigmine)
- Recent expansion of Specialty sales capabilities & comprehensive refresh of key franchise branding/marketing materials
- Support commercialization of biosimilars pipeline utilizing managed care, sales and marketing infrastructure
Leverage M&A to Augment Growth
- Priority on assets complementing current Neurology and Endocrinology infrastructure
- Build on Movement Disorders franchise by acquiring or in-licensing complementary assets
- Opportunistic expansion into other therapeutic areas (including additional Biosimilars)
8
Maximize Well-established Footprint & Infrastructure
Building a Leading Position | Offering Proven Options for | Partnering to Bring Important |
in Movement Disorders | Migraine Patients | Neuromuscular Treatments for Patients |
NeurologyIPX203
Development
Program
(Parkinson's Disease
Symptoms)
K127
Orphan Drug under development as innovative, once-daily, extended- release formulation (pyridostigmine) for treating Myasthenia Gravis
Endocrinology | Biosimilars |
& Primary | |
Care |
(1)
(1)
(2)
Biosimilar versions of innovator products.
Evaluating Add-on Opportunities that Leverage Our Existing Development & Commercialization Capabilities
9
- In-licensedfrom Kashiv Biosciences, LLC (f.k.a. Adello Biologics, LLC).
- In-licensedfrom mAbxience, a subsidiary of Spanish healthcare firm Insud Pharma.
IPX203: Grow our Movement Disorders Portfolio
- Issued patent expires November 2034
- Additional intellectual property protection expected
- Phase 3 study ongoing, top line results expected late 2020 or early 2021
Phase IIa
Comparison of IPX203 to Rytary® and to IR CD-LD
Change from Baseline in MDS-UPDRS Part III
* **
* ** * ** *
* * **
* *
*P <0.05 compared to IR CD-LD
- P<0.05 compared to Rytary
Phase IIb
Comparison of IPX203 to IR CD-LD
Value of IPX-203 to the Patient
Key Highlights
- Phase IIa results demonstrated a statistically significant improvement vs baseline in MDS-UPDRS Part III compared to both Rytary® and IR CD/LD
- Phase IIb confirmed ~2.9 hours increase in duration of good "ON" time versus IR CD/LD
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Note: IPX203 is an investigational compound which has not been approved by the FDA
Complete AvKARE Transaction
- Strategic Transaction for Delivering Value
Strengthens Presence in U.S. Federal Healthcare Market
- Aligns with Amneal's additional distribution strategy
- Enhances access to VA and DOD generics market estimated at ~$2.5 billion1
- Provides leading expertise in government contracting
Platform Well-Positioned for Growth
- Generic manufacturers outsourcing greater share of government business to resellers
- Offers multiple shots on goal for first-to-market generics from AvKARE's vendor partners
- Enables expansion into unit dose business
Provides Important Financial Benefits
- Provides upside from high-value launches by AvKARE's 132 vendor partners
- AvKARE's growing share of national contracts provides long-term revenue visibility
Received FTC Clearance 1/8/2020; Expect Feb. 2020 Close | 11 |
(1) Source: VA.gov; Open.Defense.gov
Maximize an Exceptional Platform for Growth
- Focus on expansion of vendors & product offerings as well as growing unit dose product portfolio
- Utilize Amneal's U.S. manufacturing network & AvKARE's manufacturer relationships to supply federal market
- Transaction will be immediately accretive to Amneal's earnings and be deleveraging to Amneal's balance sheet
Industry Metrics
Business Metrics
Financial Metrics
AvKARE Key Business Highlights
~$2.5 billion(1) | #2 | $47.0 billion(2) | |||
End Market | Reseller in Market | Drugs going off patent (2020-2022) | |||
132 | > 230 | 31 | |||
Existing Manufacturing Relationships | Partnered Products | National Contracts | |||
~$63.0 million(3) | 5.4x(3) | ||||
Consolidated EBITDA | Enterprise Value/Consolidated EBITDA | ||||
(1) | Source: VA.gov; Open.Defense.gov | 12 |
(2) | Wall Street Equity Research | |
(3) | Unaudited for the twelve-month period ended October 31, 2019 |
Excited About 2020 Momentum and Opportunities
Execute Strategies and Actions to:
Grow Fundamentally Strong Generics Business
Grow Specialty Franchise
Complete AvKARE Transaction & Grow the Business
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Amneal Pharmaceuticals Inc. published this content on 15 January 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 January 2020 22:57:00 UTC